Impact of Okara and Bio-okara Food Product on Gut and Glycaemic Health in Middle-aged and Older Adults in Singapore

National University of Singapore

Status: Unknown

Conditions: Aging; Blood Glucose; Gastrointestinal Microbiome; Microbiota

Treatments: Dietary Supplement: Okara biscuits; Dietary Supplement: Bio-okara biscuits; Dietary Supplement: Control biscuits

Study type: Interventional

Funder types: Other

Identifiers

NCT03978104

S4

Details and patient eligibility

About

This research project aims to provide the scientific findings about the beneficial effects of okara (soybean pulp) consumption on gut and glycaemic health in middle-aged and older individuals in Singapore. In addition, it aims to examine the health promoting impact of bio-transformed okara in this population. We hypothesise that consuming a habitual diet with an okara (untreated or bio-transformed) incorporated food product will improve the gut microbiome composition and will increase the production of short chain fatty acids when compared to a same diet with no okara. Okara-based food product can also improve the glycaemic response in individuals compared to a product without okara in meal tolerance test (acute).

Full description

For this double-blind, randomized, crossover experiment, the participants will complete a 16-week study period. Following a 1-wk pre-intervention baseline period, each participant will be randomly assigned to consume their habitual diet that either contains or do not contain okara food product (untreated and bio-transformed okara) for 3 weeks. The food product will be equivalent to a consumption of 20 g of okara (dried) per day. Following a 3-week dietary 'washout' period, the participants will be assigned to consume the other diets for another 3 weeks. This process will be repeated until each participant have completed all three interventions. Fecal and fasting-state blood samples will be obtained at study weeks 1, 4, 7, 10, 13, and 16, which correspond to before and end of the three 3-week intervention periods.

Additionally, during Weeks 1, 7 and 13, fasted participants will also be required to undergo a meal tolerance test. A cannula will first be inserted into the participant's forearm for blood sampling by a trained phlebotomist. One of three meals prepared by designated study personnel will then be randomly assigned during each visit, namely, control biscuit, untreated okara biscuit and bio-transformed okara biscuit. During each test, the participants will eat the prepared meal within 10 minutes and have blood samples drawn by intravenous cannulation at time = 0, 15, 30, 45, 60, 90, 120, 180 and 240 min, with time 0 being the time the participants first start eating the biscuits. The blood samples will analyzed for the postprandial blood glucose, insulin responses and lipid levels.

Enrollment: 20 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ability to give an informed consent
2. Age 50 to 75 years
3. Willing to follow the study procedures

Exclusion criteria

All subjects meeting any of the exclusion criteria at baseline will be excluded from participation

1. Significant change in weight (≥ 3 kg body weight) during the past 3 months
2. Allergy to soy-based products
3. Acute illness at the study baseline
4. Exercising vigorously over the past 3 months
5. Following any restricted diet (e.g. vegetarian)
6. Smoking
7. Have a daily intake of more than 2 alcoholic drinks per day
8. Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 5 years prior to the intervention participation
9. Taking dietary supplements which may impact the outcome of interests (e.g. vitamin supplements, probiotic supplement etc.)
10. Pregnant, lactating, or planning pregnancy in the next 6 months
11. Insufficient venous access to allow the blood collection
12. Very high intake of fibre/ vegetables on a daily basis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups

Okara biscuits

Experimental group

Description:

Subjects will consume their habitual diet with daily okara biscuit consumption accounting to 20 grams/ day of dry okara powder for 21 days.

Treatment:

Dietary Supplement: Okara biscuits

Bio-okara biscuits

Experimental group

Description:

Subjects will consume their habitual diet with daily bio-okara biscuit consumption accounting to 20 grams/ day of dry bio-okara powder for 21 days.

Treatment:

Dietary Supplement: Bio-okara biscuits

Control biscuits

Experimental group

Description:

Subjects will consume their habitual diet with daily control biscuit consumption for 21 days.

Treatment:

Dietary Supplement: Control biscuits